# K970785: Sims Hyperinflation Bag System

- Pathway: 510(k) (Traditional)
- Applicant: Sims
- Decided: Jun 13, 1997 after 101 days
- Product code: NHK (Resuscitator, Manual, Non Self-Inflating)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092687: Venti.Plus Hyperinflation Bag System with Pressure Manometer (2009), 1 descendant of its own
- K102377: Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O; Ventiplus Disposable Manometer 0 (2010), 0 descendants of its own

## Indications for use
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffeging from respiratory insufficiency. Typical treatment consists of hyperinflating the patient’s lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer. The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffeging from respiratory insufficiency. Typical treatment consists of hyperinflating the patient’s lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.

Source page: https://510kreport.com/device/K970785
Methodology: https://510kreport.com/methodology